NCT01246323

Brief Summary

The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 5, 2011

Status Verified

November 1, 2010

Enrollment Period

2 years

First QC Date

November 14, 2010

Last Update Submit

August 4, 2011

Conditions

Pain

Keywords

Visual analogue scalepain levelanalgesiacombined anesthesia

Outcome Measures

Primary Outcomes (2)

  • Pain level

    Pain level will be evaluated every 4 hours from the time of surgery to discharge

    For the first 72 hours following surgery

  • Number of doses of analgesic drugs

    Number of doses of analgesic medications will be collected from patients charts.

    For the first 72 hours following surgery

Study Arms (2)

combined anesthesia

ACTIVE COMPARATOR

Patients will receive spinal and general anesthesia for benign laparoscopy gynecological surgery

Procedure: Spinal anesthesia with Fentanyl+ Morphine

Control

NO INTERVENTION

Interventions

Spinal anesthesia with Fentanyl+ MorphinePROCEDURE

Fentanyl 15 microgram Morphine 0.1-0.5 mg

combined anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
  • Benign Gynecological Laparoscopy surgery

You may not qualify if:

  • Patients who are not capable to sign the consent form.
  • Women with known allergy to the medication used in spinal analgesia.
  • Patients who are pregnant or lactating.
  • Patients with contraindication to spinal analgesia.
  • Patients who use opioid on a regular base.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

Rambam Health Care Campus

Haifa, 9602, Israel

NOT YET RECRUITING

Related Publications (4)

  • Jones T, Tilsley DW, Wilson CB, Lammertsma AA, Brown G, Brady F, Price PM. Positron emission tomography for tumour assessment. NMR Biomed. 1992 Sep-Oct;5(5):265-9. doi: 10.1002/nbm.1940050512.

    PMID: 1449966BACKGROUND

  • Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24. doi: 10.1046/j.1365-2044.2000.055002118.x.

    PMID: 10651671BACKGROUND

  • Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73. doi: 10.1046/j.1365-2044.2002.02873.x.

    PMID: 12437707BACKGROUND

  • Karaman S, Kocabas S, Uyar M, Zincircioglu C, Firat V. Intrathecal morphine: effects on perioperative hemodynamics, postoperative analgesia, and stress response for total abdominal hysterectomy. Adv Ther. 2006 Mar-Apr;23(2):295-306. doi: 10.1007/BF02850135.

    PMID: 16751162BACKGROUND

MeSH Terms

Conditions

PainAgnosia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Lior Lowenstein

    Rambam Health Care Campus

    STUDY CHAIR

Central Study Contacts

Lior Lowenstein, MD, MS

CONTACT

050-2061434LowensteinMD@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2010

First Posted

November 23, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

August 5, 2011

Record last verified: 2010-11

Locations

IL(2)